Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN

Not Applicable

• Conditions: Cancer Survivors; Chemotherapy-induced Peripheral Neuropathy
• Interventions: Behavioral: Online intervention

• Registration Number: NCT05371158
• Lead Sponsor: Daniëlle van de Graaf

Brief Summary

Rationale: An average of 30% of adult cancer survivors suffers from chemotherapy-induced peripheral neuropathy (CIPN) ≥ 6 months after completion of chemotherapy, and their quality of life (QoL) is strongly affected due to these symptoms. Treatment options are limited.

Objective: The goal of this study is to examine the effectiveness of an online psychological intervention based on Acceptance and Commitment Therapy (ACT) in a Randomized Controlled Trial (RCT) and compared to a treatment-as-usual control condition (TAU). We aim to improve pain interference in cancer survivors with chronic painful CIPN (present for at least 3 months) in the curative disease phase who were treated with chemotherapy treatment at least 6 months ago (irrespective of disease site).

Study design: It concerns a test of effectiveness of the ACT intervention in an RCT on quality of life. In total, 146 participants will be randomly allocated to one of two groups: the online ACT intervention with therapist email guidance or a control condition that receives treatment-as-usual. Patients in the control condition can follow the online ACT intervention directly after the 3 month-follow up measurement. Self-reported questionnaires will be conducted at baseline, after the intervention, and at 3- and 6-month follow-up. Additionally, interviews will be executed with a subgroup of interested patients afterwards, to explore intervention effects more in-depth. Participants will be sampled via various patient organizations, oncologists, and advertisements distributed via the PROFILES-registry that contains ongoing research projects on CIPN. Data will be collected online via the PROFILES-registry.

Study population: The population consists of adult cancer survivors in the curative disease phase suffering from painful CIPN for at least 3 months and who received chemotherapy treatment 6 or more months ago.

Intervention: An online ACT intervention was developed in the first phase of the QLIPP-CIPN study. In this study phase insights into daily limitations and quality of life of the patient population were gained, which served as the basis of the patient-centered development of the online ACT intervention following the CeHRes roadmap for participatory eHealth design. The intervention includes an 8-week self-management course containing 6 modules regarding psycho-education and ACT- processes. By means of text and exercises people learn to carry out value-oriented goals in daily life with pain. To do this, they learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Additionally, participants will receive email guidance.

Main study parameters/endpoint: Pain interference in daily life using subscale Interference of the Multidimensional Pain Inventory (MPI). This scale focuses on a psychosocial aspect of chronic pain, specifically the interference with functioning in, for example, work, homework chores, recreational and social activities due to pain.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation is not expected to have any risks. Participants can quit the study at any moment and will not be excluded based on medication use or other current treatment for CIPN. If participants regress during the intervention and need new chemotherapy treatment, they can choose if they will continue or not. Participants do need to invest time to follow the intervention, which takes around 2 hours per week. Furthermore, it might be confronting to work on pain acceptance for participants. Benefits of participation are foremost a possible improvement in pain interference and reductions in pain and CIPN symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-03-16
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Study First Posted: 2022-05-12
• Last Update Posted: 2022-05-12
• Primary Completion: 2023-03-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online intervention	Online intervention	The experimental condition includes an online psychological intervention with therapist email guidance based on Acceptance \& Commitment Therapy (ACT). ACT is a form of Cognitive Behavioral Therapy, which focuses on acceptance of chronic pain in order to be able to perform valuable activities, instead of attempts of avoidance and controlling (Hayes et al., 2012). The main goal of ACT is increasing psychological flexibility, which includes the ability to act effectively according to personal values, with pain. ACT can thereby play a role in creating more realistic expectations regarding expectations of future pain relief. The intervention can be worked through in the participant's own living environment. It consists of 6 modules which can be worked through in 8 weeks.

Primary Outcome Measures

Name	Time	Method
Pain interference	T5 (8 months)	Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

Secondary Outcome Measures

Name	Time	Method
Cancer related quality of life	T5 (8 months)	European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.
Psychological distress	T5 (8 months)	Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.
CIPN symptom severity	T5 (8 months)	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.
Pain catastrophizing	T5 (8 months)	Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.
Psychological flexibility	T4 (5 months)	Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).
Mindfulness	T5 (8 months)	Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.
Pain intensity	T5 (8 months)	Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.
Intervention evaluation (Based on: Trompetter et al. (2015)).	T5 (8 months) (WLC)	Questions: * During the past few weeks, how many hours did you spend on average per week working on the online course?; * On average, how many days per week did you do mindfulness exercises during the past few weeks?; * On the days you practiced mindfulness: On average, how many minutes did you spend practicing?; * How do you rate the quality of the online training you received?; * Did you receive the kind of help you were hoping to receive?; * To what extent did the online training meet your needs?; * Suppose one of your acquaintances needed the same help, would you recommend the online training?; * How satisfied are you with the amount of help you received?; * Did the online training help you cope better with your problems?; * Overall, how satisfied are you with the online training you received?; * Would you do the online training again if you needed to?; * What grade would you give the online training?
Adherence	T5	Adherence will be based on technical data obtained from Karify's online environment. The following information will be used for this purpose.; * Sent messages: the moment when a message is sent to the supervisor.; * Given feedback: the moment when feedback is given on a specific assignment.; * Significant moment: first_viewed: the moment when an assignment is viewed for the first time.; * Significant moment: finished: the moment when an assignment is handed in for the first time.; This will possibly be combined with the number of hours spent on intervention (self-reported), as described under 'intervention evaluation'.
Values-based living	T5 (8 months)	Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.

Trial Locations

Locations (1)

Tilburg University; 🇳🇱 Tilburg, Noord-Brabant, Netherlands